Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead 
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 0 Diseases   10 Trials   10 Trials   41 News 


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  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Trial termination:  B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults (clinicaltrials.gov) -  Aug 17, 2022   
    P4,  N=30, Terminated, 
    Trial completion date: Feb 2025 --> Sep 2025 | Trial primary completion date: Jan 2023 --> Aug 2023 Completed --> Terminated; Difficulties enrolling participants
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Trial completion date, Trial primary completion date:  Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant (clinicaltrials.gov) -  Aug 3, 2022   
    P4,  N=18, Recruiting, 
    Controlled studies are needed to verify acceptable pharmacokinetic and pharmacodynamic metrics for crushed B/FTC/TAF given via tube, with and without tube feeds, before use in this manner. Trial completion date: Dec 2022 --> Feb 2024 | Trial primary completion date: Sep 2022 --> Dec 2023
  • ||||||||||  Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD), Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    New P3 trial:  DAWN: Doravirine and Weight Gain in Antiretroviral Naive (clinicaltrials.gov) -  Jul 14, 2022   
    P3,  N=150, Not yet recruiting, 
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Enrollment closed, Enrollment change:  B/F/TAF Switch Study for HIV-HBV Coinfection (clinicaltrials.gov) -  Jul 14, 2022   
    P4,  N=28, Active, not recruiting, 
    Switching from triple therapy with RPV to B/F/TAF is a safe and effective strategy in real life. Recruiting --> Active, not recruiting | N=60 --> 28
  • ||||||||||  Dovato (dolutegravir/lamivudine) / ViiV Healthcare, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Enrollment open, Trial completion date, Trial primary completion date:  PASO-DOBLE: DTG/3TC Vs. BIC/FTC/TAF Maintenance Therapy in People Living with HIV: (clinicaltrials.gov) -  Jun 24, 2022   
    P4,  N=550, Recruiting, 
    BIC/FTC/TAF may be a good option for PEP. Not yet recruiting --> Recruiting | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Dec 2022 --> Jan 2025
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Enrollment open, Enrollment change, Trial completion date, Trial primary completion date:  BICOLDER: Switch to TAF+FTC+BIC in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication (clinicaltrials.gov) -  Jun 10, 2022   
    P4,  N=27, Recruiting, 
    Trial completion date: Jun 2024 --> Jun 2023 Not yet recruiting --> Recruiting | N=50 --> 27 | Trial completion date: Jun 2021 --> Jun 2022 | Trial primary completion date: Jan 2021 --> Dec 2021
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Enrollment closed:  BFTAF Elderly Switch Study (clinicaltrials.gov) -  May 24, 2022   
    P3,  N=520, Active, not recruiting, 
    Not yet recruiting --> Recruiting | N=50 --> 27 | Trial completion date: Jun 2021 --> Jun 2022 | Trial primary completion date: Jan 2021 --> Dec 2021 Recruiting --> Active, not recruiting
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Engagement in HIV care and on-going substance use: a qualitative sub-study of BASE participants () -  May 12, 2022 - Abstract #AIDS2022AIDS_2742;    
    P4
    The development of this mid-range explanatory theory of engagement in HIV care for PWH/SUD highlights the significant role of layered stigma, as well as the importance of recognizing and utilizing interpersonal motivation to help overcome barriers to engagement in HIV care. Results have implications for clinical care and intervention development.
  • ||||||||||  Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD)
    Intermittent doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF) maintains viral suppression in real life in controlled HIV-infected patients () -  May 12, 2022 - Abstract #AIDS2022AIDS_764;    
    One VF occurred at W38 (HIV-RNA=61 and 76 copies/mL), in a patient reporting a good compliance, without resistance at baseline, with no emergence of resistance, and with HIV-RNA <50 copies/mL after resumption of daily tenofovir alafenamide/emtricitabine/bictegravir. This observational study shows the potential for the NNRTI next-generation DOR/3TC/TDF regimen given intermittently to maintain a high virological success rate, while reducing cumulative exposition and cost of ART.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Safety and efficacy of switching to BIC/FTC/TAF plus DOR in HIV-infected patients with multiclass-resistant virus () -  May 12, 2022 - Abstract #AIDS2022AIDS_757;    
    This study evaluated the safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide (RPV/FTC/TAF) plus dolutegravir (DTG), to BIC/FTC/TAF plus DOR in multiclass-resistant patients... Switching from RPV/FTC/TAF plus DTG to BIC/FTC/TAF plus DOR in HIV-infected males with multiclass-resistant virus was well tolerated and efficacious with an advantageous AE profile and no food restrictions.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    A pilot study of the impact of a rapid ART initiation in advanced HIV disease () -  May 12, 2022 - Abstract #AIDS2022AIDS_747;    
    These results demonstrate the durability and safety of B/F/TAF in PWH. Our results support the efficacy, safety and feasibility of a rapid start strategy with B/F/TAF in patients with advanced HIV.
  • ||||||||||  Advanced HIV infection in the US: immune response to ART initiation () -  May 12, 2022 - Abstract #AIDS2022AIDS_745;    
    In the OPERA cohort, all ART-naïve, adults with advanced HIV (CD4200 cells/µL). No difference was observed in CD4:CD8 ratio changes over time across groups; CD4:CD8 ratio normalization was rare with all regimens.
  • ||||||||||  Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, Tivicay (dolutegravir) / ViiV Healthcare
    Change in weight and BMI associated with switching to bictegravir/emtricitabine/tenofovir alafenamide vs. a dolutegravir-based regimen among a prospective longitudinal cohort of virologically suppressed adults living with HIV () -  May 12, 2022 - Abstract #AIDS2022AIDS_703;    
    Of 956 enrolled, 673 switched to BIC/F/TAF, 148 switched to F/TAF plus DTG, 51 switched to DTG/ABC/3TC, 48 switched to DTG/RPV and 36 switched to DTG/3TC...Compared to switching from integrase strand transfer inhibitors (INSTIs), switching from efavirenz (EFV) was associated with significantly higher annualized weight gain post-switch (+3.11 kg/year, p<0.001), whereas switching from RPV was associated with significantly lower annualized weight gain post-switch (-2.17 kg/year, p=0.022)... In this real-world cohort, switching to a BIC vs. DBR were both associated with lower annualized weight gain post-switch that was not significantly different at Week 48; however, patients switching from EFV gained significantly more weight, while those switching from RPV gained significantly less weight post-switch compared to those switching from INSTIs.